MUSTANG?

Description of Event or Problem

IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT FOREARM. A 5.0 X 40, 75CM MUSTANG BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 15 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

Additional Manufacturer Narrative

A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER. D2B - PRO CODE (PRODUCT CODE): FGE, LIT. E1 - INITIAL REPORTER CITY: (B)(6). G4 - PREMARKET / 510(K) #: K141521, K141597. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT CONDITION.